A Follow-up Study of Women Evaluated and Treated for Infertility
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Ovarian Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Women's Studies, Endometrial Cancer, Thyroid Cancer |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 11/11/2018 |
| Start Date: | June 5, 1996 |
Follow-Up Study of Women Evaluated and Treated for Infertility
To assess the relations of infertility causes and treatment to cancer risk, we will conduct a
retrospective cohort study of approximately 12,000 women evaluated for infertility between
1965-1988. These women will be ascertained from several large infertility clinics and private
practices in various geographic locations in the United States: Boston, Chicago, Detroit, New
York, and Palo Alto. These practices were selected on the basis of their having large number
of patients who received ovulation stimulating drugs many years in the distant past.
Abstractors reviewed clinic medical records to identify eligible study participants and
abstract data needed to classify causes of infertility and document therapies employed. Using
a variety of tracing sources (including the National Death Index, credit bureaus, and
postmasters), the vital status and location of the study subjects were determined. Subjects
who were traced and identified as alive are being sent a detailed questionnaire that requests
information on their health status as well as on a number of lifestyle practices. For
subjects who report a cancer, medical verification is being sought from the diagnosing
physicians and/or facilities. Death certificates are being sought for deceased subjects.
retrospective cohort study of approximately 12,000 women evaluated for infertility between
1965-1988. These women will be ascertained from several large infertility clinics and private
practices in various geographic locations in the United States: Boston, Chicago, Detroit, New
York, and Palo Alto. These practices were selected on the basis of their having large number
of patients who received ovulation stimulating drugs many years in the distant past.
Abstractors reviewed clinic medical records to identify eligible study participants and
abstract data needed to classify causes of infertility and document therapies employed. Using
a variety of tracing sources (including the National Death Index, credit bureaus, and
postmasters), the vital status and location of the study subjects were determined. Subjects
who were traced and identified as alive are being sent a detailed questionnaire that requests
information on their health status as well as on a number of lifestyle practices. For
subjects who report a cancer, medical verification is being sought from the diagnosing
physicians and/or facilities. Death certificates are being sought for deceased subjects.
BACKGROUND: We previously conducted a retrospective cohort study of 12,193 patients evaluated
for infertility between 1960-1988 at five clinical sites. Detailed information abstracted
from the medical records, along with questionnaires administered to located patients and
cancer incidence and mortality data derived from cancer registries and the National Death
Index, allowed us to examine cancer risk related to different causes of infertility and
treatments while controlling for other patient characteristics. Although there were some
increases of certain cancers related to various causes of infertility, we generally did not
observe substantial relationships related to use of different fertility drugs. The one
exception was some increased risk of uterine cancers with clomiphene use, of interest given
the drug's chemical similarity to tamoxifen. Our numbers of patients with certain cancers
(e.g., ovarian, uterine) were, however, limited and we had insufficient power to evaluate
subgroup effects (e.g., drug relationships among nulligravid women).
OBJECTIVES: We therefore conducted an updated follow-up of these patients in order to assess
cancer risk in relation to causes of infertility and therapeutic regimens used to treat these
causes.
ELIGIBILITY: This study gained an additional 10 years of follow-up among the patients deemed
eligible for the previous investigation. This included women with both primary and second
infertility. Approximately 39% of the cohort previously were prescribed clomiphene citrate,
while 10% received gonadotrophins.
DESIGN: Passive follow-up was attempted for patients who previously did not participate and
for whom only information available in clinic records could be retained. All other patients
were traced for active as well as passive follow-up. Active follow-up involved requesting
that patients complete a short questionnaire, whereas passive follow-up was via linkage to
cancer registries and the National Death Index. While cancer risks were assessed in relation
to the general population, the majority of comparisons were internal ones, involving the
calculation of relative risks (RRs) associated with different causes of infertility or
treatment regimens while controlling for other cancer risk predictors.
for infertility between 1960-1988 at five clinical sites. Detailed information abstracted
from the medical records, along with questionnaires administered to located patients and
cancer incidence and mortality data derived from cancer registries and the National Death
Index, allowed us to examine cancer risk related to different causes of infertility and
treatments while controlling for other patient characteristics. Although there were some
increases of certain cancers related to various causes of infertility, we generally did not
observe substantial relationships related to use of different fertility drugs. The one
exception was some increased risk of uterine cancers with clomiphene use, of interest given
the drug's chemical similarity to tamoxifen. Our numbers of patients with certain cancers
(e.g., ovarian, uterine) were, however, limited and we had insufficient power to evaluate
subgroup effects (e.g., drug relationships among nulligravid women).
OBJECTIVES: We therefore conducted an updated follow-up of these patients in order to assess
cancer risk in relation to causes of infertility and therapeutic regimens used to treat these
causes.
ELIGIBILITY: This study gained an additional 10 years of follow-up among the patients deemed
eligible for the previous investigation. This included women with both primary and second
infertility. Approximately 39% of the cohort previously were prescribed clomiphene citrate,
while 10% received gonadotrophins.
DESIGN: Passive follow-up was attempted for patients who previously did not participate and
for whom only information available in clinic records could be retained. All other patients
were traced for active as well as passive follow-up. Active follow-up involved requesting
that patients complete a short questionnaire, whereas passive follow-up was via linkage to
cancer registries and the National Death Index. While cancer risks were assessed in relation
to the general population, the majority of comparisons were internal ones, involving the
calculation of relative risks (RRs) associated with different causes of infertility or
treatment regimens while controlling for other cancer risk predictors.
- INCLUSION CRITERIA:
The following criteria for inclusion in the study cohort will apply:
Patient is female.
Patient was evaluated for infertility between (and including) 1965 and 1988.
Patient had a U.S. address at the time of evaluation for infertility.
Patient was seen twice by the physician, or was seen once but had a referral from another
physician.
Patient's infertility was not due to gonadal dysgenesis or congenital abnormalities of the
reproductive system.
Patient's visit to the infertility specialist was not to have a tubal ligation reversed.
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